FREDS ANTIBACTERIAL FRESH PEAR (TRICLOSAN) LIQUID [FREDS INC.]

FREDS ANTIBACTERIAL FRESH PEAR (TRICLOSAN) LIQUID [FREDS INC.]
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NDC 55315-185-08
Set ID ac8fa8b0-74af-421e-88a4-9cfe38a03bf4
Category HUMAN OTC DRUG LABEL
Packager FREDS INC.
Generic Name
Product Class
Product Number
Application Number PART333E
  • ACTIVE INGREDIENT

    TRICLOSAN 0.46%

    PURPOSE

    ANTIBACTERIAL

  • USES

    HELPS REDUCE BACTERIA ON THE SKIN.

  • WARNINGS

    FOR EXTERNAL USE ONLY.

    WHEN USING THIS PRODUCT

    STOP USING THIS PRODUCT AND ASK DOCTOR IF

    KEEP OUT OF REACH OF CHILDREN

    IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

  • DIRECTIONS

    APPLY ONTO DRY HANDS. WORK INTO A RICH FOAMY LATHER, RINSE AND DRY THOROUGHLY.

  • OTHER INFORMATION

    STORE AT ROOM TEMPERATURE.

  • INACTIVE INGREDIENTS:

    WATER (AQUA), SODIUM XYLENESULFONATE, DIPROPYLENE GLYCOL, GLYCERIN, SODIUM PCA, AMMONIUM LAURYL SULFATE, COCAMIDOPROPYL BETAINE, POLYQUATERNIUM-10, FRAGRANCE (PARFUM), DISODIUM PHOSPHATE, CETYL ALCOHOL, ALOE BARBADENSIS LEAF JUICE, CITRIC ACID, METHYLPARABEN, PROPYLPARABEN, GREEN 3 (CI 42053), YELLOW (CI 47005).

  • PRINCIPAL DISPLAY PANEL

    IMAGE OF THE LABEL

  • INGREDIENTS AND APPEARANCE
    FREDS  ANTIBACTERIAL FRESH PEAR
    triclosan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-185
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.46 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)  
    SODIUM PHOSPHATE, DIBASIC ANHYDROUS (UNII: 22ADO53M6F)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55315-185-08222 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/25/2012
    Labeler - FREDS INC. (005866116)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture(55315-185)

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